Z-0284-2021 Class II Terminated
FDA device recall Z-0284-2021 was initiated by Philips North America, LLC on September 14, 2020 and is designated Class II. Reason for recall: The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has … The recall status is terminated (terminated September 13, 2022). Affected quantity: 8,942.
Recall Details
- Product Type
- Devices
- Report Date
- November 4, 2020
- Initiation Date
- September 14, 2020
- Termination Date
- September 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,942
Product Description
Philips Sterilizable Defibrillator Paddles, Switched Internal Paddles, Model Numbers M4741A, M4742A, M4743A, M4744A - Product Usage: used in pairs to transmit a controlled electrical shock from an external defibrillator directly to the exposed heart muscle of a post-pubescent patient in order to intentionally stop start the heartbeat during cardiopulmonary surgery.
Reason for Recall
The periodic Paddle Checks recommended in the Instructions for Use for Sterilizable Defibrillator Paddles may not detect one failure mode for the Switched Internal Defibrillator Paddles. Philips has created an addendum to the IFU, that includes a test for the switched paddles only, which will detect this failure mode.
Distribution Pattern
Global Distribution. US Nationwide.
Code Information
All units manufactured and distributed January 2015 to August 2020.